Payne v. Novartis Pharm. Corp.
| Decision Date | 18 August 2014 |
| Docket Number | No. 13–6266.,13–6266. |
| Parties | Charolette PAYNE; Brent Payne, Plaintiffs–Appellants, v. NOVARTIS PHARMACEUTICALS CORPORATION, Defendant–Appellee. |
| Court | U.S. Court of Appeals — Sixth Circuit |
OPINION TEXT STARTS HERE
Reversed and remanded. ARGUED: Clinton L. Kelly, The Kelly Firm, Hendersonville, Tennessee, for Appellants. Eric G. Lasker, Hollingsworth LLP, Washington, D.C., for Appellee. ON BRIEF:
Clinton L. Kelly, F. Dulin Kelly, The Kelly Firm, Hendersonville, Tennessee, for Appellants. Eric G. Lasker, Katharine R. Latimer, Hollingsworth LLP, Washington, D.C., Dwight E. Tarwater, Paine, Tarwater, and Bickers LLP, Knoxville, Tennessee, for Appellee.
BEFORE: CLAY and STRANCH, Circuit Judges; BLACK, District Judge. *
Charolette Payne and her husband sued Novartis for failing to warn her doctor that two of the drugs it manufactures, Aredia and Zometa, could cause serious damage to a patient's jaw bones. Payne took both and subsequently had to have part of her jaw removed. Under Tennessee law, the question of whether Novartis's failure to warn was a cause of Payne's injuries is for a jury to determine. We therefore REVERSE the district court's grant of summary judgment for Novartis.
Answering the question presented by this failure-to-warn claim requires that we “unravel the tangled skein of fact and policy” that goes by the deceptively unassuming name “causation.” Wex S. Malone, Ruminations on Cause–in–Fact, 9 Stan. L.Rev. 60, 60 (1956). Causation issues in failure-to-warn cases present particularly knotty problems. First, they involve a series of counterfactual constructs—had you known certain facts, what would you have done?—that we use to determine “cause in fact.” Restatement (Third) of Torts: Phys. & Emot. Harm § 28 cmt b. Would the doctor have changed his behavior if he had known about the drug's side effect? If so, would the doctor's actions have altered the patient's? And would the patient's altered actions have reduced the harm the drug caused her? These, like all causation issues, are “ordinarily jury questions, unless the uncontroverted facts and inferences to be drawn from them make it so clear that all reasonable persons must agree on the proper outcome.” Haynes v. Hamilton Cnty., 883 S.W.2d 606, 612 (Tenn.1994); see also 63A Am.Jur.2d Prod. Liab. § 1138 (May 2014).
Because the answers to such questions are essentially unknowable and clouded by hindsight biases and credibility concerns (and thus especially suitable for the jury), at summary judgment these kinds of cases often hinge on the mix of moral intuition and policy judgments we call “proximate cause.” See Dobbs' Law of Torts § 185; Waste Mgmt. Inc. of Tenn. v. S. Cent. Bell Tel. Co., 15 S.W.3d 425, 430 (Tenn.Ct.App.1997). Plaintiffs must show, among other things, that the drug manufacturer's failure to warn was a “substantial factor” in the harm the drug caused the patient. Hale v. Ostrow, 166 S.W.3d 713, 719 (Tenn.2005). This is also normally a question for the jury. See Haynes, 883 S.W.2d at 612. The legal significance of the warning's absence may also be dependent on particular facts such as dosage prescribed, prescription time frame, the patient's medical profile—to list a few common considerations.
Not only are these cases enormously fact-specific and fact-intensive, they are state-specific: the same set of facts that could get a plaintiff to the jury in one jurisdiction could very well result in summary judgment for the drug manufacturer in another. Woe to the party in a failure-to-warn case who thinks that cases from other jurisdictions will guarantee victory in her own. States have adopted a variety of legal rules that simplify the causation analysis; some rules benefit the pharmaceutical company (and shift liability to the prescribing doctor), some the injured patient. See, e.g., Giles v. Wyeth, Inc., 500 F.Supp.2d 1063, 1065–69 (S.D.Ill.2007); see also Garside v. Osco Drug, Inc., 976 F.2d 77, 82–83 (1st Cir.1992); 1 Madden & Owen on Prod. Liab. § 9:11 (3d ed.2000).
Here, two factual issues carry the plaintiffs past summary judgment: Payne's doctor made clear that he would have warned Payne had he known that Aredia and Zometa can destroy a patient's jaw bones, and Payne testified that she would not have taken the drugs had she been aware of the risk of this side effect.
Aredia and Zometa Patterson v. Novartis Pharm. Corp., 451 Fed.Appx. 495, 496 (6th Cir.2011). They are, however, associated with osteonecrosis of the jaw (ONJ). “Osteonecrosis of the jaw results in the gums being eaten away until the bone is exposed” and then dies from lack of blood. Id. The connection between biophosphonates and ONJ began to come to light to the medical community in the early 2000's. Courts in other bisphosphonate cases found to be probative evidence that Novartis was aware of the risk of ONJ years earlier. See, e.g., Mahaney ex rel. estate of Kyle v. Novartis Pharm. Corp., 835 F.Supp.2d 299, 311 (W.D.Ky.2011); Rowland v. Novartis Pharm. Corp., 9 F.Supp.3d 553, 2014 WL 1316351, at *3 (W.D.Penn.2014). Other ONJ plaintiffs have “presented evidence showing that Novartis's high-ranking officials knew about the drugs' side effects and subverted medical inquiries into such effects.” Fussman v. Novartis Pharm. Corp., 509 Fed.Appx. 215, 224 (4th Cir.2013) (per curiam); see also Davids v. Novartis Pharm. Corp., 977 F.Supp.2d 171, 183 (E.D.N.Y.2013). “Novartis knew of the risk of ONJ as early as 2002, but instructed its sales force not to mention the disease when making calls to physicians.” Winter v. Novartis Pharm. Corp., 739 F.3d 405, 409 (8th Cir.2014).
In 1999 Charolette Payne's breast cancer spread to her bones. That same year, her physician, Dr. Darrell Johnson, prescribed Aredia, unaware of the risk of the ONJ. In 2001, Dr. Johnson switched her to Zometa; again, Dr. Johnson was not aware of the risk of ONJ. In 2005, Dr. Johnson noticed something wrong with Payne's jaw and advised her to see a dentist. He also suspended her Zometa treatment. He later explained why:
There were some data coming out about that time that Aredia and Zometa can be associated with complications of the mandible that can increase the risk of what we call osteonecrosis of that jaw and I believe that—you know, within a year or so of that there were some data coming out and saying that if you have a patient that you're suspicious of something like that possibly going on[,] holding the medication may be wise while they're undergoing evaluation by a dentist.
Payne had several teeth removed but “was displeased with her oral surgeon's performance and continued to feel pain in the area from which her teeth were extracted.” In 2007, Dr. Johnson noticed that one of Payne's teeth was partially necrotic. Payne's oral surgeon diagnosed her with biophosphonate-induced ONJ. Her condition progressed; part of Payne's jaw had to be removed in 2009.
“Had I been warned that Aredia and Zometa may cause Osteonecrosis of the jaw, I would not have taken those drugs,” Payne later stated in an affidavit. Dr. Johnson testified that he continues to prescribe Aredia and Zometa but now warns his patients about the risk of ONJ and recommends that they get a dental exam before they start treatment.
Payne and her husband sued Novartis in 2008, alleging in relevant part that her ONJ was the result of Novartis's failure to provide adequate warnings about the link between biophosphonates and the disease. Payne's was one of many such suits. The judicial panel on multidistrict litigation transferred her case to the Middle District of Tennessee for consolidated proceedings. The MDL court remanded her case in March 9, 2012, and it was subsequently transferred to the Eastern District of Tennessee.
The district court granted summary judgment for Novartis on one ground: That Novartis's alleged failure to warn was not a proximate cause of Payne's ONJ. Under Tennessee's “learned intermediary doctrine,” the court stated, the question was whether a jury could find that Dr. Johnson would have done something differently had he known about the risk of ONJ and, if so, whether that difference could have prevented Payne's ONJ. The court dismissed as “entirely speculative” Payne's statement that she would have refused biophosphonates if she had been warned about the risk of ONJ.
On appeal, the Paynes argue that a jury could find that Payne would not have developed ONJ if Novartis had warned Dr. Johnson about the risk. The Paynes' argument is straightforward: If Novartis had warned Dr. Johnson, Dr. Johnson would have warned Payne and Payne would have refused to take biophosphonates. Novartis focuses on what it characterizes as the district court's evidentiary decision to “exclude” Payne's statement that she would not have taken Aredia or Zometa had she known the risk. As Novartis's counsel said at oral argument, this case “does rise and fall on whether or not the district court acted within its discretion ... to disregard the affidavit as being entirely speculative.”
The panel reviews the district court's grant of summary judgment de novo. Laster v. City of Kalamazoo, 746 F.3d 714, 726 (6th Cir.2014). Summary judgment is appropriate only if the pleadings, depositions, answers to interrogatories, and affidavits show there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a) & (c). The burden to show that there are no genuine issues of material fact falls on the parties seeking summary judgment. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91...
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